Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2016 to 30 April 2016 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2016-05-27
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product, veterinary drug








C_2016189EN.01000101.xml










27.5.2016   


EN


Official Journal of the European Union


C 189/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2016 to 30 April 2016
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2016/C 189/01)
—   Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted













Date of the decision


Name of the medicinal product


INN (International Non-Proprietary Name)


Holder of the marketing authorisation


Number of the entry in the Community Register


Pharmaceutical form


ATC code (Anatomical Therapeutic Chemical Code)


Date of notification




4.4.2016


Rasagiline Mylan


rasagiline


Mylan S.A.S
117 allée des Parcs, F-69800 Saint Priest, France


EU/1/16/1090


Tablet


N04BD02


6.4.2016




8.4.2016


Palonosetron Hospira


palonosetron


Hospira UK Limited
Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom


EU/1/16/1100


Solution for injection


A04AA05


12.4.2016




21.4.2016


Descovy


emtricitabine/tenofovir alafenamide


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/16/1099


Film-coated tablet


J05AR17


25.4.2016




25.4.2016


Lonsurf


trifluridine/tipiracil


Les Laboratoires Servier
50 rue Carnot, F-92284 Suresnes Cedex, France


EU/1/16/1096


Film-coated tablet


L01BC


27.4.2016




25.4.2016


Taltz


ixekizumab


Eli Lilly Nederland B.V.
Papendorpseweg 83, 3528 BJ Utrecht, Nederland


EU/1/15/1085


Solution for injection


L04AC13


28.4.2016




—   Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted










Date of the decision


Name of the medicinal product


Holder of the marketing authorisation


Number of the entry in the Community Register


Date of notification




4.4.2016


Gardasil 9


Sanofi Pasteur MSD SNC
162 avenue Jean Jaurès, 69007 Lyon, France


EU/1/15/1007


6.4.2016




4.4.2016


Humira


AbbVie Ltd
Maidenhead, SL6 4UB, United Kingdom


EU/1/03/256


6.4.2016




4.4.2016


Opdivo


Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom


EU/1/15/1014


6.4.2016




4.4.2016


Revolade


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/10/612


6.4.2016




4.4.2016


Telzir


ViiV Healthcare UK Limited
980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom


EU/1/04/282


6.4.2016




4.4.2016


Xgeva


Amgen Europe B.V.
Minervum 7061, NL-4817 ZK Breda, Nederland


EU/1/11/703


6.4.2016




7.4.2016


Dafiro HCT


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/09/574


11.4.2016




7.4.2016


Imprida


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/06/373


11.4.2016




7.4.2016


Ziagen


ViiV Healthcare UK Limited
980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom


EU/1/99/112


11.4.2016




8.4.2016


Entacapone Orion


Orion Corporation
Orionintie 1, FI-02200 Espoo, Suomi


EU/1/11/708


12.4.2016




8.4.2016


INCRELEX


Ipsen Pharma
65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France


EU/1/07/402


12.4.2016




8.4.2016


Zyprexa


Eli Lilly Nederland B.V.
Papendorpseweg 83, 3528 BJ Utrecht, Nederland


EU/1/96/022


12.4.2016




13.4.2016


Cholib


BGP Products Ltd
Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead SL6 4XE, United Kingdom


EU/1/13/866


15.4.2016




13.4.2016


Ibandronic acid Sandoz


Sandoz GmbH
Biochemiestrasse 10, A-6250 Kundl, Österreich


EU/1/11/685


15.4.2016




13.4.2016


Ixiaro


Valneva Austria GmbH
Campus Vienna Biocenter 3, A-1030 Wien, Österreich


EU/1/08/501


15.4.2016




13.4.2016


Jakavi


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/12/773


15.4.2016




13.4.2016


Nemdatine


Actavis Group PTC ehf.
Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland


EU/1/13/824


15.4.2016




13.4.2016


Paliperidone Janssen


Janssen-Cilag International NV
Turnhoutseweg 30, B-2340 Beerse, België


EU/1/14/971


15.4.2016




13.4.2016


Ryzodeg


Novo Nordisk A/S
Novo Allé, DK-2880 Bagsvaerd, Danmark


EU/1/12/806


15.4.2016




13.4.2016


Tamiflu


Roche Registration Limited
6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom


EU/1/02/222


15.4.2016




13.4.2016


Tresiba


Novo Nordisk A/S
Novo Allé, DK-2880 Bagsvaerd, Danmark


EU/1/12/807


15.4.2016




13.4.2016


Vectibix


Amgen Europe B.V.
Minervum 7061, NL-4817 ZK Breda, Nederland


EU/1/07/423


15.4.2016




13.4.2016


Zypadhera


Eli Lilly Nederland B.V.
Papendorpseweg 83, 3528 BJ Utrecht, Nederland


EU/1/08/479


15.4.2016




18.4.2016


Exjade


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/06/356


20.4.2016




18.4.2016


Tysabri


Biogen Idec Limited
Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom


EU/1/06/346


20.4.2016




21.4.2016


Abilify


Otsuka Pharmaceutical Europe Ltd
Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom


EU/1/04/276


25.4.2016




21.4.2016


Bonviva


Roche Registration Limited
6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom


EU/1/03/265


25.4.2016




21.4.2016


Dasselta


Krka, d. d., Novo Mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenija


EU/1/11/739


25.4.2016




21.4.2016


Desloratadine ratiopharm


ratiopharm GmbH
Graf-Arco-Straße 3, D-89079 Ulm, Deutschland


EU/1/11/746


25.4.2016




21.4.2016


Exviera


AbbVie Ltd
Maidenhead, SL6 4UB, United Kingdom


EU/1/14/983


25.4.2016




21.4.2016


Helicobacter Test INFAI


INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH
Universitätsstraße 142, D-44799 Bochum, Deutschland


EU/1/97/045


25.4.2016




21.4.2016


Nplate


Amgen Europe B.V.
Minervum 7061, NL-4817 ZK Breda, Nederland


EU/1/08/497


25.4.2016




21.4.2016


Temozolomide SUN


Sun Pharmaceutical Industries Europe BV
Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland


EU/1/11/697


25.4.2016




21.4.2016


Yervoy


Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom


EU/1/11/698


25.4.2016




21.4.2016


Zoely


Teva B.V.
Swensweg 5, 2031 GA Haarlem, Nederland


EU/1/11/690


25.4.2016




25.4.2016


Bondronat


Roche Registration Limited
6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom


EU/1/96/012


27.4.2016




25.4.2016


Competact


Takeda Pharma A/S
Dybendal Alle 10, 2630 Taastrup, Danmark


EU/1/06/354


27.4.2016




25.4.2016


Cubicin


Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom


EU/1/05/328


27.4.2016




25.4.2016


Invokana


Janssen-Cilag International NV
Turnhoutseweg 30, B-2340 Beerse, België


EU/1/13/884


27.4.2016




25.4.2016


Jardiance


Boehringer Ingelheim International GmbH
Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland


EU/1/14/930


27.4.2016




25.4.2016


Picato


Leo Pharma A/S
Industriparken 55, DK-2750 Ballerup, Danmark


EU/1/12/796


27.4.2016




25.4.2016


Trizivir


ViiV Healthcare UK Limited
980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom


EU/1/00/156


27.4.2016




25.4.2016


Tysabri


Biogen Idec Limited
Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom


EU/1/06/346


27.4.2016




28.4.2016


ABILIFY MAINTENA


Otsuka Pharmaceutical Europe Ltd
Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom


EU/1/13/882


3.5.2016




28.4.2016


Forxiga


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/12/795


2.5.2016




28.4.2016


Levetiracetam ratiopharm


ratiopharm GmbH
Graf-Arco-Straße 3, D-89079 Ulm, Deutschland


EU/1/11/702


2.5.2016




28.4.2016


Synjardy


Boehringer Ingelheim International GmbH
Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland


EU/1/15/1003


2.5.2016




28.4.2016


Viekirax


AbbVie Ltd
Maidenhead, SL6 4UB, United Kingdom


EU/1/14/982


3.5.2016




28.4.2016


Vokanamet


Janssen-Cilag International NV
Turnhoutseweg 30, B-2340 Beerse, België


EU/1/14/918


2.5.2016




28.4.2016


Xigduo


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/13/900


2.5.2016




28.4.2016


ZALTRAP


Sanofi-Aventis groupe
54 rue La Boétie, F-75008 Paris, France


EU/1/12/814


2.5.2016




—   Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted













Date of the decision


Name of the medicinal product


INN (International Non-Proprietary Name)


Holder of the marketing authorisation


Number of the entry in the Community Register


Pharmaceutical form


ATC code (Anatomical Therapeutic Chemical Code)


Date of notification




18.4.2016


Evalon


Coccidiosis vaccine live for chickens


Laboratorios Hipra, S.A.
Avda. La Selva, 135, E-17170- Amer (Girona), España


EU/2/16/194


Suspension and solvent for oral spray


QI01AN01


20.4.2016




20.4.2016


LETIFEND


Recombinant Protein Q from L. infantum MON-1


Laboratorios LETI, S.L.unipersonal
C/Del Sol 5, Polígono Industrial Norte Tres Cantos, 28760 Madrid, España


EU/2/16/195


Lyophilisate and solvent for solution for injection


QI07A


22.4.2016




—   Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted










Date of the decision


Name of the medicinal product


Holder of the marketing authorisation


Number of the entry in the Community Register


Date of notification




4.4.2016


Meloxidolor


Le Vet Beheer B.V.
Wilgenweg 7, NL-3421 TV Oudewater, Nederland


EU/2/13/148


6.4.2016




12.4.2016


BTVPUR


Merial
29 avenue Tony Garnier, F-69007 Lyon, France


EU/2/10/113


14.4.2016




12.4.2016


Poulvac E. coli


Zoetis Belgium S.A.
Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique


EU/2/12/140


14.4.2016




18.4.2016


CERTIFECT


Merial
29 avenue Tony Garnier, F-69007 Lyon, France


EU/2/11/125


20.4.2016




18.4.2016


Clomicalm


Elanco Europe Ltd
Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom


EU/2/98/007


20.4.2016




18.4.2016


ECOPORC SHIGA


IDT Biologika GmbH
Am Pharmapark, D-06861 Dessau-Rosslau, Deutschland


EU/2/13/149


20.4.2016




18.4.2016


Pexion


Boehringer Ingelheim Vetmedica GmbH
Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland


EU/2/12/147


20.4.2016




18.4.2016


Profender


Bayer Animal Health GmbH
D-51368 Leverkusen, Deutschland


EU/2/05/054


20.4.2016




18.4.2016


Zulvac 1 Bovis


Zoetis Belgium S.A.
Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique


EU/2/11/130


20.4.2016




18.4.2016


Zulvac 1 Ovis


Zoetis Belgium S.A.
Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique


EU/2/11/131


20.4.2016




20.4.2016


Aftovaxpur Doe


Merial
29 avenue Tony Garnier, F-69007 Lyon, France


EU/2/13/153


22.4.2016




20.4.2016


Oncept IL-2


Merial
29 avenue Tony Garnier, F-69007 Lyon, France


EU/2/13/150


22.4.2016




27.4.2016


Draxxin


Zoetis Belgium S.A.
Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique


EU/2/03/041


29.4.2016




27.4.2016


Naxcel


Zoetis Belgium S.A.
Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique


EU/2/05/053


29.4.2016




Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:





European Medicines Agency




30 Churchill Place




Canary Wharf




London E14 5EU




United Kingdom






(1)  OJ L 136, 30.4.2004, p. 1.